Comparing long-term and short-term hormone therapy with radiation for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of long-term versus short-term adjuvant androgen deprivation therapy (ADT) combined with high-dose salvage radiotherapy in patients who experience biochemical relapse after radical prostatectomy for prostate cancer. It is a randomized, multicenter, prospective trial that focuses on node-negative patients with specific adverse pathological features. The study will assess the impact of these treatment durations on distant metastasis-free survival, providing insights into optimal management strategies for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* History of histologically proven prostate cancer, treated with RP and ePLND. All patients have to be pN0. The minimal template for ePLND is defined as the removal of the external iliac, internal iliac and obturator nodes (standard template). Removal of the presacral and common iliac nodes is left at the discretion of the treating urologist.
* Asymptomatic PSA-rise post-RP, defined as a value equal to or more than 0.2µg/l and at least confirmed once (interval ≥2 weeks, confirmation PSA level should be higher). In case of Gleason 8-10, pT3b or R1 resection, an asymptomatic PSA-rise post-RP starting from ≥0.15 µg/l is allowed for inclusion. If the PSA-level is less than 0.4 ng/ml, no additional staging for distant metastasis is required before inclusion in the trial. The patient will be offered the opportunity to participate in a diagnostic sub-study with investigational imaging with 18F PSMA PET CT. However in case of PSA-level \>0.4 ng/ml, biological imaging using 18F-PSMA or 68Ga-PSMA is mandatory as this is not considered investigational anymore. Therefore the patient cannot anymore take part in the diagnostic sub-study and (un-blinded) PET-CT is obligatory to rule out lymph node (N) and /or distant metastasis (M1a-c) before inclusion.
* Testosterone levels within above 150 ng/dl.
* ECOG 0-1
* Life expectancy more than 5 years
* Signed informed consent

Exclusion Criteria:

* Presence of pN1 disease at original surgical specimen.
* Presence of distant metastasis at time of referral (M1a-c). If PSA more than 0.4 ng/ml, imaging with PET-CT is required to rule out distant metastasis (see above). Other additional imaging modalities (CT scan, bone scintigraphy...) are allowed but left at the discretion of the treating centre.
* Undetectable PSA (less than 0.2 ng/ml) at time of referral.
* Previous RT making new RT impossible (overlapping treatment fields).
* Known contraindications to irradiation (Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia…)
* Active treatment with ADT or PSA modulating drugs (finasteride, dutasteride, high-dose corticoids…)
* Not able understanding treatment protocol or signing informed consent.

Where it's running

• AZ Maria Middelares
  Ghent, Belgium Recruiting
• UZ Gent
  Ghent, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Study coordinator: Charlien Berghen, MD
• Email: charlien.berghen@uzleuven.be
• Phone: 003216345217

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.